Establishing Guidelines for Manual Lymphatic Drainage (MLD)

The purpose of this study is to establish optimal guidelines for Manual Lymphatic Drainage in participants with lower extremity lymphedema.

Study Overview

• Status: Completed
• Conditions: Lymphedema of Leg
• Intervention / Treatment: Procedure: Pressure

Detailed Description

To determine if there is a difference in L-Dex Score and Segmental Limb Volume in participants with lower extremity lymphedema as measured in liters by the SOZO machine between participants who receive Manual Lymphatic Drainage (MLD) techniques utilizing light tactile pressure with 5-10 mmHg without skin stretch versus medium tactile pressure of 11-20 mmHg and medium skin stretch with therapist in a stationary position, versus firm tactile pressure (> 21 mmHg) and maximal skin stretch with therapist weight shift.

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Anschutz Medical Campus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• All adults between the age of 30 - 75 years
• Lower extremity lymphedema

Exclusion Criteria:

• Pregnant women
• Participants who are unable to stand independently for up to 2 mins
• Participants who cannot make their own decisions
• Participants undergoing cancer treatment
• Participants with an Infection (active cellulitis)
• Participants with a known Iodine Allergy
• Participants who weigh more than 375 lbs
• Participants with cardiac arrhythmias or implanted electronic equipment
• Participants who have undergone joint replacement in involved extremity
• Participants with cardiac insufficiency

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Light Tactile Pressure; light tactile pressure with 5-10 mmHg without skin stretch	Procedure: Pressure; Subjects are randomized to one of three treatment groups
Active Comparator: Medium Tactile Pressure; medium tactile pressure of 11-20 mmHg and medium skin stretch with therapist in a stationary position	Procedure: Pressure; Subjects are randomized to one of three treatment groups
Active Comparator: Firm Tactile Pressure; firm tactile pressure (> 21 mmHg) and maximal skin stretch with therapist weight shift	Procedure: Pressure; Subjects are randomized to one of three treatment groups

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in The L-dex (Lymphedema Index).	The L-DEX score represents the difference in the amount of extracellular fluid in an at-risk limb compared to an unaffected limb.	18 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Total body weight in liters	All the water within a person's body, including both intracellular and extracellular fluid. Expressed as volume (liters or pints) and percentage of total weight (%).	18 Months
Change in Extracellular Fluid in liters	All fluid that is not contained within the cells. Expressed as volume (liters or pints) and percentage of TBW (%).	18 months
Change in Intracellular Fluid in liters	• Description: All fluid contained within the cells. Expressed as volume (liters or pints) and percentage of TBW (%).	18 Months
Change in Skeletal Muscle Mass in lbs	The amount of mass a person has that is made up of fat. Expressed in kgs or lbs and percentage of total weight (%)	18 Months
Change in Fat Mass in lbs	The amount of mass a person has that is made up of fat. Expressed in kgs or lbs and percentage of total weight (%)	18 Months
Change in Free Fat Mass in lbs	The amount of mass a person has that contains no fat (lean body mass). Includes muscle, connective tissue, organs, body water and bone. Expressed in kgs or lbs and percentage of total weight (%).	18 Months
Change in Basal Metabolic Rate (BMR) in lbs	Daily amount of energy a person's body burns when at complete rest. Expressed in calories.	18 Months
Change in Basal Metabolic Rate in kg/m^2	A relationship between weight and height that is associated with body fat and health risks. BMI = weight / height2.	18 months

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Investigators: Principal Investigator: Marco Del Chiaro, University of Colorado Denver | Anschutz

Study record dates

Study Major Dates

• Study Start (Actual): July 20, 2022
• Primary Completion (Actual): April 30, 2023
• Study Completion (Actual): April 30, 2023

Study Registration Dates

• First Submitted: July 24, 2022
• First Submitted That Met QC Criteria: August 17, 2022
• First Posted (Actual): August 19, 2022

Study Record Updates

• Last Update Posted (Actual): January 11, 2024
• Last Update Submitted That Met QC Criteria: January 10, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Lymphatic Diseases; Lymphedema
• Other Study ID Numbers: 22-0733

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No